Postoperative or Salvage Radiotherapy (RT) for Node Negative Prostate Cancer Following Radical Prostatectomy
Recruiting · NCT00969111 · Interventional (participants receive a specific treatment) · Lead sponsor: Proton Collaborative Group
View the official record on ClinicalTrials.gov →Interventions studied
IMRT to 45 Gy; prostate bed proton boost of 21.6 CGEIMRT to 45 Gy; proton boost to prostate bed to 25.2 CGEProton (prostate bed) to 70.2 CGEProton to 66.6 CGE
What this trial is about
The purpose of this study is to see what effects, good and/or bad, proton radiation, and/or conventional radiation and hormonal therapy (if applicable), has on prostate cancer that has already returned or the risk of prostate cancer returning.
Who can take part
Age range
18 Years and older
Sex
Male
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- Prostate cancer treated primarily with open, laparoscopic or robotically assisted prostatectomy.
- Maximum PSA value of 20 ng/ml.
Exclusion criteria
- Evidence of distant metastasis (M1).
- Prior systemic chemotherapy for any reason.
- Previous irradiation to the pelvis that would compromise the ability to deliver the prescribed study treatment.
- Active inflammatory bowel disease (Crohn's disease, diverticulitis or ulcerative colitis) affecting the rectum. (Non-active diverticulitis and Crohn's disease not affecting the rectum are allowed).
- Prior or concurrent cancer, other than non-melanomatous skin cancer, unless disease free for at least 5 years.
- Taking Saw Palmetto or methotrexate and unable or unwilling to discontinue its use during radiation.
Where it is running
6 locations listed across 6 US states.
- Proton Center of Arkansas - Little Rock, Arkansas, United States
- University of Florida Proton Therapy Institute - Jacksonville, Florida, United States
- Northwestern Medicine Chicago Proton Center - Warrenville, Illinois, United States
- McLaren Proton Therapy Center - Flint, Michigan, United States
- Mercy David C. Pratt Cancer Center - St Louis, Missouri, United States
- Inova Schar Cancer Institute - Fairfax, Virginia, United States